Single Use Hemoclip by Zhejiang Chuangxiang Medical Technology Co., LTD.

The proposed device Single Use Hemoclip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

AI/ML Overview

The provided text is a 510(k) summary for the "Single Use Hemoclip" device. It outlines the device's characteristics, indications for use, and comparison to predicate devices, along with performance data. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study that proves the device meets them, particularly for AI/human reader performance.

This document focuses on the substantial equivalence of a medical device (a hemoclip) to previously cleared devices based on physical and mechanical properties, not on the performance of a diagnostic AI algorithm that would typically involve acceptance criteria related to sensitivity, specificity, or human reader studies.

Here's an analysis of what information is present and what is missing from the provided text:

Information Present:

Device Name: Single Use Hemoclip
Predicate Devices: Sterile Repositionable Hemostasis Clipping Device (K152001) and SureClipTM Repositionable Hemostasis Clip (K161463).
Bench Tests Performed:
- Appearance
- Dimensional verification
- Clamping Strength Testing
- Release Force Testing
- Open and Close Mechanical Integrity of Clip Assembly
- Tensile Strength Testing
- Rotation Testing
Conclusion from Bench Tests: "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent."
Clinical Study: "No clinical study is included in this submission."
Ground Truth for Manufacturing/Bench Testing: Implied by ISO standards (ISO 10993, ISO 11135-1, ISO 10993-7) and the specific bench tests (e.g., dimensional verification would involve measuring against design specifications).

Information Missing (and why it's missing from this specific document type):

The majority of your questions are relevant to the evaluation of a diagnostic AI device or a device where human interpretation or a specific performance metric (like accuracy, sensitivity, specificity) is key to its safety and effectiveness. This document describes a physical medical device (a hemoclip) and its physical and mechanical performance. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/diagnostic algorithm are not directly applicable here.

Here's why many of your specific questions cannot be answered from this document:

Table of acceptance criteria and reported device performance (for AI): Not applicable. The "performance data" listed are for mechanical integrity and dimensions, not diagnostic accuracy.
Sample size used for the test set and data provenance (e.g. country of origin, retrospective/prospective): Not applicable for an AI test set. The "tests" were bench tests on the physical device. The relevant "sample size" would be the number of devices tested for each bench test, which is not detailed here. No patient data is involved.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical device's mechanical properties is based on engineering specifications and measurement standards, not expert reader consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human interpretation requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size: No. Clinical studies were not conducted, and this is not a diagnostic device requiring human reader evaluation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the ground truth would be the engineering design specifications and industry standards for mechanical performance (e.g., how much force the clip should withstand, its dimensions). This is implied by the listed ISO standards.
The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) pertains to a physical medical device (a hemoclip) and its substantial equivalence based on bench testing of mechanical and physical properties. The framework of acceptance criteria and study design you've described (particularly questions 2-6 and 8-9) is primarily relevant to diagnostic AI/machine learning devices or clinical studies involving diagnostic accuracy or human interpretation, which are not detailed or applicable in this specific regulatory submission for this type of device.

The "acceptance criteria" for this device would be its ability to meet the specified mechanical and dimensional requirements, demonstrating equivalence to the predicate devices, as shown by the listed bench tests. The full details of these bench tests (e.g., the number of clips tested for clamping strength, the specific force values) are not provided in this summary but would be part of the full 510(k) submission.

Summary

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March 20, 2018

Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long Quality Supervisor 301B, No.22, XinYan Road Hanzhou. Zhejiang 311100 China

Re: K172762

Trade/Device Name: Single Use Hemoclip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: February 5, 2018 Received: February 5, 2018

Dear Lucius Long:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible and well-defined. The background has a faint watermark.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172762

Device Name Single Use Hemoclip

Indications for Use (Describe)

The Single Use Hemoclip device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

(1) endoscopic marking,

(2) hemostasis for
(a) mucosal / sub-mucosal defects < 3cm,
(b) bleeding ulcers,
(c) polyps < 1.5cm in diameter,

(d) diverticula in the colon,

(3) as a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively

(4) the age of the intended population for the device is for patients who are 18 and older.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 4 510(k) Summary( 21CFR 807.92)

1. Submitter's information

Name: Zhejiang Chuangxiang Medical Technology Co., LTD.

Address: 301B, No.22, XinYan Road Yuhang Economic And Technological Development Zone Hangzhou Zhejiang China

Contact person: Lucius.Long Telephone: 86-571-89167088-8187 Fax: 86-571-89167086

2. Device

Name of the device: Single Use Hemoclip Classification name: Hemorrhoidal ligator Regulation class: 2 Regulation number:876.4400 Panel: Gastroenterology/Urology Product code: PKL

3. Predicate device

510(k) Number: K152001, Product Name: Sterile Repositionable Hemostasis Clipping Device

510(k) Number: K161463 Product Name: SureClipTM Repositionable Hemostasis Clip 4. Device description

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Image /page/4/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a green and blue hexagon shape on the left, followed by the company name in blue and green. The text "MEDNOVA" is in green, and the other text is in blue.

5.Indication for use

The Single Use Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

(1) endoscopic marking,
(2) hemostasis for
(a) mucosal / sub-mucosal defects < 3cm,
(b) bleeding ulcers,
(c) polyps < 1.5cm in diameter,
(d) diverticula in the colon,

(3) as a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively

(4) the age of the intended population for the device is for patients who are 18 and older.

Summary of comparison of technological characteristics with the predicate device

The Single Use Hemoclip incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Micro-Tech predicate devices.

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Image /page/5/Picture/1 description: The image contains a logo for MEDNOVA. The logo consists of a green and blue hexagon shape on the left, with the text "MEDNOVA" in blue and green below it. To the right of the hexagon shape, there are three Chinese characters in blue.

Comparison to Predicate Devices:
Item	Proposed device	Predicate device	Additional predicate device	Comparison toPredicateDevices
Device name	Single use hemoclip	Sterile repositionablehemostasis clipping device	SureClipTM RepositionableHemostasis Clip	Similiar
510(k) number	K172762	K152001	K161463	Different 510(k)number
Manufacturer	Zhejiang Chuangxiang medicaltechnology Co., Ltd.	Micro-Tech(Nanjing) Co., Ltd.	Micro-Tech(Nanjing) Co., Ltd.	Differentmanufacturer
Product Code	PKL	PKL	PKL	Same
Regulation No.	876.4400	876.4400	876.4400	Same
Class	2	2	2	Same
Supplied Sterile	Yes	Yes	Yes	Same
Configuration	Delivery system and clip assembly	Delivery system and clipassembly	Delivery system and clipassembly	Same
Open width	9mm, 12mm,13mm,15mm	11mm	8mm, 11mm and 16mm	similar
Minimal workingchannel	2.8mm	2.8mm	2.8mm	Same
Working Length	1650mm, 1950mm, 2300mm,2700mm	1650mm,1950mm,2350mm,2700mm	1650mm, 1950mm ,2350mm,2700mm	similar
Indications forUse	The single use hemoclip is indicatedfor endoscopic clip	The Sterile RepositionableHemostasis Clipping	The SureClipTMRepositionableHemostasis	similarThe indications for
	placement within the	Device is indicated for	Clip is indicated for endoscopic	use of proposed
	gastrointestinal tract for	endoscopic clip	clip	device is narrow than
	the purpose of:	placement within the	placement within the	predicate device, the
	(1) endoscopic marking,	gastrointestinal tract for	gastrointestinal tract for	age of the intended
	(2) hemostasis for	the purpose of:	the purpose of:	population for the
	(a) mucosal / sub-mucosal defects <	(1) endoscopic marking,	(1) endoscopic marking,	proposed device is
	3cm,	(2) hemostasis for	(2) hemostasis for	patients who are 18
	(b) bleeding ulcers,	(a) mucosal / sub-mucosal	(a) mucosal / sub-mucosal	and older.
	(c) polyps < 1.5cm in diameter,	defects < 3cm,	defects < 3cm,
	(d) diverticula in the colon,	(b) bleeding ulcers,	(b) bleeding ulcers,
	(3) as a supplementary method,	(c) polyps < 1.5cm in diameter,	(c) polyps < 1.5cm in diameter,
	closure of GI tract luminal	(d) diverticula in the colon,	(d) diverticula in the colon,
	perforations <20mm that can be	(3) as a supplementary method,	(3) as a supplementary method,
	treated conservatively	closure of GI tract luminal	closure of GI tract luminal
	(4)the age of the intended	perforations <20mm that can be	perforations <20mm that can be
	population for the device is for	treated conservatively	treated conservatively
	patients who are 18 and older.
				Similar
Repositionability				Proposed device can
				reopened and
	Clip reopened and repositioned up	Clip reopened and repositioned	Clip reopened and repositioned	repositioned up to 8
	to 8 times	up to 5 times	up to 5 times	times, predicate
				device can reopened
				and repositioned up
				to 5 times. Both arewithin their claimedperformancecharacteristics .
Single Use	Yes	Yes	Yes	Same
Packaging	Single-use EO sterilized pouch withone device per pouch	Single-use EO sterilized pouchwith one device per pouch	Single-use EO sterilized pouchwith one device per pouch	Same
Shelf Life	Three years	Three years	Three years	Same

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Image /page/6/Picture/1 description: The image contains a logo with a blue and green color scheme. On the left side of the logo is a geometric shape with a gradient from green to blue. To the right of the shape is the text "MEDNOVA" in blue, with the "MED" portion in a darker shade of blue and the "NOVA" portion in a lighter shade of blue. Above the text "MEDNOVA" is Chinese characters in blue.

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Image /page/7/Picture/1 description: The image contains a logo with a green and blue color scheme. On the left side of the logo, there is a geometric shape that resembles a shield or emblem, with a gradient from green to blue. To the right of the emblem, there is text in blue that appears to be Chinese characters, followed by the word "MEDNOVA" in green and blue. The overall design is modern and professional, suggesting a company or organization with a focus on innovation and technology.

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Image /page/8/Picture/1 description: The image contains a logo with a hexagon shape on the left side that transitions from green to blue. To the right of the logo, there is text in blue that appears to be Chinese characters. Below the Chinese characters, the word "MEDNOVA" is written, with "MED" in blue and "NOVA" in green.

7. Performance data

The proposed device the Single Use Hemoclip meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals",

The following bench tests were performed on the Single Use Hemoclip:

Appearance
Dimensional verification
Clamping Strength Testing
Release Force Testing

Open and Close Mechanical Integrity of Clip Assembly Tensile Strength Testing Rotation Testing

The testing performed demonstrated that the proposed and predicate delivery systems are equivalent.

Clinical Test Conclusion

No clinical study is included in this submission.

9. Conclusions

Based on the indications for use, technological characteristics, and safety and performance testing, Single Use Hemoclip has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared the Sterile Repositionable Hemostasis Clipping Device (K152001) and SureClipTM Repositionable Hemostasis Clip (K161463).

Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.